Since the Supreme Court overturned Roe v. Wade, access to mifepristone, one of two drugs used in medication abortion, has become a focal point of legal, political, and public debate despite its long safety record. Over 25 years ago, the FDA approved mifepristone, along with a requirement that the drug be dispensed in person by a physician. In 2023, after research that continued to demonstrate its safety, the FDA eliminated the requirement that the drug be dispensed in person, enabling the drug to be mailed or dispensed by retail pharmacies. This change has allowed clinicians to dispense the drug via mail and enabled tens of thousands of patients to access medication abortion in states where abortion is outlawed.
The most recent installment in efforts to restrict access to mifepristone by abortion opponents involves a case brought by the state of Louisiana challenging the agency’s 2023 decision to eliminate the prior in-person dispensing requirement. The court has paused further legal proceedings for six months while the FDA continues an internal review of the drug’s safety. Louisiana has filed a notice of appeal with the 5th Circuit. Unless the 5th Circuit overturns the district court, over the next six months, the Biden-era FDA dispensing requirements permitting mifepristone to be distributed to patients by mail can stand. In its ruling, the district court emphasized that the FDA is best equipped to evaluate the scientific evidence, with the judiciary serving as a check to ensure the agency fulfills its statutory responsibilities, but not to replace its role. However, the transition from the Biden administration, which embraced reproductive rights, to the Trump administration, which supports abortion restrictions, could mark a shift in the FDA’s approach. Recently, a letter from HHS Secretary Kennedy and FDA Commissioner Makary cites a methodologically flawed report published by a conservative anti-abortion organization as a justification to launch an internal review of the safety of mifepristone.
Dissatisfied with the pace of the FDA review, Senator Josh Hawley, an anti-abortion leader, has introduced the Safeguarding Women from Chemical Abortion Act, which would rescind the FDA’s approval of mifepristone. He has also launched an investigation into mifepristone manufacturers Danco Laboratories and GenBioPro seeking information about adverse events associated with the drug, claiming that the drug is risky based on the results of the same flawed report cited by HHS officials.
Medication abortion accounts for over two-thirds of U.S. abortions, and telehealth access has expanded its use significantly. As abortion opponents have pressured the FDA and the courts to reconsider the approval of mifepristone, reproductive rights supporters have emphasized the drug’s 25 -year safety record and some even consider the FDA’s revised dispensing requirements as medically unnecessary limitations to abortion access.
For now, the FDA’s current dispensing rules for mifepristone remain in place while this case is paused, and related litigation continues. The FDA has filed motions in three other cases asking those federal courts to pause the litigation until it completes the internal review. Despite calls from Republican leaders and anti-abortion organizations for the FDA to act quickly, the Louisiana district court has given the FDA until October 7, 2026, one month before the midterms, to file a report with the status of its review and any updated timeframe for completion. In the meantime, clinicians may continue to mail mifepristone to pregnant patients seeking abortions regardless of where they live.